Phase 3
N=40
Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
Meniere Disease
Bottom Line
View on ClinicalTrials.gov: NCT04218123 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Number of Vertigo Episodes — 5.41; 5.03; 13.78 number of episodes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Venlafaxine (Drug); Placebo oral tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Vertigo Episodes |
5.41; 5.03; 13.78 | <0.001 sig |
| PRIMARY Severity of Vertigo |
16; 24; 38; 32; 30; 32 | — |
| SECONDARY Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey |
14.92; 14.54; 13.81; 4.62; 4.6; 4.38 | =0.31 |
| SECONDARY Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI) |
46.81; 46.31; 50.68 | =0.538 |
| SECONDARY Change in Score on Penn State Worry Questionnaire (PSWQ) |
44.35; 45.63; 47.16 | =0.686 |
| SECONDARY Change in Score on Patient Health Questionnaire (PHQ9) |
5.49; 7.17; 7.43 | =0.167 |
| SECONDARY Change in Score on Cognitive Failure Questionnaire (CFQ) |
33.92; 36.4; 36.14 | =0.8 |
| SECONDARY Change in Score on Neuropsychological Vertigo Inventory (NVI) |
59.41; 63.31; 65.11 | =0.425 |
| SECONDARY Change in Score on Dizziness Handicap Inventory (DHI) |
45.46; 45.2; 55.62 | =0.054 |
Summary
As of yet, the cause of Meniere's disease is uncertain and there is no cure. Given the lack of high level evidence for treatments, we seek to perform a randomized, placebo-controlled, double-blind, crossover, pilot trial of venlafaxine for treating Meniere's disease. Venlafaxine is a safe and well-tolerated medication. It has never been trialed in Meniere's disease, but there is evidence that it could be effective in helping with vertigo attacks and other aspects of the disorder.
Eligibility Criteria
Study subjects will be prospectively recruited from the population of patients presenting with dizziness to our tertiary, multidisciplinary, vestibular-focused, neurotology clinic. Subjects must meet the following inclusion criteria:
- be 18 years of age or older;
- have definite MD as defined by the Barany Society 2015 international consensus statement;
- have active MD with at least 2 vertigo episodes in the month prior to enrollment; and score at least 36 on the Dizziness Handicap Inventory (DHI), representing at least moderate handicap.
Patients with the following will be excluded:
- other concurrent vestibular or balance disorder (especially those with vestibular migraine-related vertigo episodes despite not meeting diagnostic criteria for vestibular migraine);
- currently taking venlafaxine, SSRIs, or SNRIs;
- history of medical (e.g. gentamicin) or surgical (e.g. labyrinthectomy) vestibular ablative treatment;
- history of otologic, lateral skull base, or brain surgery;
- history of radiation to the head or neck;
- known neurologic disorder affecting cognition;
- currently taking another serotonin modulating medication;
- seizures;
- stroke;
- myocardial infarction;
- hepatic or renal impairment;
- hyperlipidemia;
- coagulopathy;
- psychiatric disorder other than anxiety or depression;
- glaucoma;
- uncontrolled hypertension;
- pregnancy or intention of pregnancy.
Data sourced from ClinicalTrials.gov (NCT04218123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.